Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors

Arrhythmias, Cardiac Clinical Trial

Official title:

Comparative Analysis in Detection of Atrial Arrhythmia and Electrogram Quality in Three Different Insertable Cardiac Monitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04471584
• Other study ID #: KCHRF-ILR-0003
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparative analysis of available ILR devices models Abbot Confirm RxTM, Medtronic Reveal LINQTM, and Biotronik BIOMONITOR., evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Description:

All devices have different algorithms for arrhythmia detection and structural design. Consequently, these devices vary in sensitivity of arrhythmia detection and data transmission.Therefore, we aim to expand a comparative analysis of available devices, evaluating detection performance and effective of transmission of these devices to better understand the differences between them.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients > 18 years of age with appropriate indication for ILR for atrial arrhythmia management. Exclusion Criteria: Inability to give consent

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Device:
• Insertion of ILR device
All patients enrolled will be randomized to have one of three ILR devices implanted (BIOMONITOR III, Reveal LinQ, or Confirm RX) and will be given event monitoring device for concurrent evaluation.

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (9)

Ciconte G, Saviano M, Giannelli L, Calovic Z, Baldi M, Ciaccio C, Cuko A, Vitale R, Giacopelli D, Conti M, Lipartiti F, Giordano F, Maresca F, Moscatiello M, Vicedomini G, Santinelli V, Pappone C. Atrial fibrillation detection using a novel three-vector cardiac implantable monitor: the atrial fibrillation detect study. Europace. 2017 Jul 1;19(7):1101-1108. doi: 10.1093/europace/euw181. — View Citation

Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Pürerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16. — View Citation

Kapa S, Epstein AE, Callans DJ, Garcia FC, Lin D, Bala R, Riley MP, Hutchinson MD, Gerstenfeld EP, Tzou W, Marchlinski FE, Frankel DS, Cooper JM, Supple G, Deo R, Verdino RJ, Patel VV, Dixit S. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. 2013 Aug;24(8):875-81. doi: 10.1111/jce.12141. Epub 2013 Apr 11. — View Citation

Lauschke J, Busch M, Haverkamp W, Bulava A, Schneider R, Andresen D, Nägele H, Israel C, Hindricks G, Bänsch D. New implantable cardiac monitor with three-lead ECG and active noise detection. Herz. 2017 Sep;42(6):585-592. doi: 10.1007/s00059-016-4492-7. Epub 2016 Oct 28. — View Citation

Lee R, Mittal S. Utility and limitations of long-term monitoring of atrial fibrillation using an implantable loop recorder. Heart Rhythm. 2018 Feb;15(2):287-295. doi: 10.1016/j.hrthm.2017.09.009. Epub 2017 Sep 13. Review. — View Citation

Nölker G, Mayer J, Boldt LH, Seidl K, VAN Driel V, Massa T, Kollum M, Brachmann J, Deneke T, Hindricks G, Jung W, Brunner KJ, Kraus S, Hümmer A, Lewalter T. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. 2016 Dec;27(12):1403-1410. doi: 10.1111/jce.13089. Epub 2016 Oct 7. — View Citation

Palmisano P, Accogli M, Zaccaria M, Luzzi G, Nacci F, Anaclerio M, Favale S. Predictive factors for pacemaker implantation in patients receiving an implantable loop recorder for syncope remained unexplained after an extensive cardiac and neurological workup. Int J Cardiol. 2013 Oct 9;168(4):3450-7. doi: 10.1016/j.ijcard.2013.04.179. Epub 2013 May 20. — View Citation

Parry SW, Matthews IG. Implantable loop recorders in the investigation of unexplained syncope: a state of the art review. Heart. 2010 Oct;96(20):1611-6. doi: 10.1136/hrt.2010.193417. Review. — View Citation

Pecha S, Aydin MA, Ahmadzade T, Hartel F, Hoffmann B, Steven D, Willems S, Reichenspurner H, Wagner FM. Implantable loop recorder monitoring after concomitant surgical ablation for atrial fibrillation (AF): insights from more than 200 continuously monitored patients. Heart Vessels. 2016 Aug;31(8):1347-53. doi: 10.1007/s00380-015-0735-4. Epub 2015 Aug 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive predictive values of device detected atrial arrhythmias	Positive predictive values of device detected atrial arrhythmias	12 months